NCT01499628|Completed
EFFECT:Eccentric Fixation From Enhanced Clinical Training
EFFECT
Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD
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EFFECT
Eccentric Fixation From Enhanced Clinical Training (EFFECT): A Randomised Clinical Trial for Patients With AMD
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Funder
interventional
200
1 country
1
Study Start
April 27, 2011
Actual (reported)Primary Completion
November 26, 2015
Actual (reported)Study Completion
December 31, 2015
Actual (reported)Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in the UK, Europe and N America. Low vision patients with AMD have great difficulty reading, which leads to a loss of independence and reduced quality of life. Magnifiers alone do not compensate for loss of central vision in AMD. It has been proposed that special low vision training can improve reading ability in patients with AMD. Training programmes are widely available in the US and Scandinavia, but not in the UK, partly because there is a lack of evidence from Randomised Control Trials (RCT) showing that they are effective. The investigators are conducting a clinical trial comparing the conventional hospital-based low vision service to enhanced rehabilitation programmes that include Eccentric Viewing training. Eccentric viewing training involves teaching patients who have lost their central vision to use a new area of retina for visual tasks. Patients are either taught to improve the use of the part of the retina they naturally start using after their central vision is lost, their so-called preferred retinal locus (PRL), or, alternatively, they are taught to use a different retinal area that is thought to be better suited for everyday visual tasks, the so-called trained retinal locus (TRL). The investigators plan to compare the two types of eccentric viewing training to conventional hospital-based low vision care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2011
Actual (reported)December 20, 2011
Actual (reported)December 26, 2011
Actual (reported)November 26, 2015
Actual (reported)December 31, 2015
Actual (reported)Score on the Massof Activity Inventory - 6 month follow up
Change from Baseline in Massof Activity Inventory at 6 month follow up
Reading Speed (ReST) - Final Assessment
Change from Baseline in Reading Speed (ReST) at Final Assessment
Quality of Life (MacDQoL) - Final Assessment
Change from Baseline in Quality of Life (MacDQoL) at Final Assessment
Quality of Life (MacDQoL) - 6 month follow up
Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up
Quality of Life (MacDQoL) - 12 month follow up
Change from Baseline in Quality of Life (MacDQol) at 12 month follow up
Self-reported health status (EQ-5D) - Final Assessment
Change from Baseline in EQ-5D score at Final Assessment
No extra training will be given.
The same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks.
Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.
Participant attends once a week for three weeks for a 45 minute appointment of supervised reading using appropriate spectacles and/or glasses
Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.
Moorfields Eye Hospital
London, EC1V 2PD, United Kingdom
Gary S Rubin, PhD
University College, London
200 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2011
First Posted
December 26, 2011
Study Start
April 27, 2011
Actual (reported)Eccentric viewing training at the Trained Retinal Locus (TRL), using reading/target cards and microperimeter. Three 45 minute sessions completed over three weeks.
Participant attends once a week for three weeks for a 45 minute appointment of TRL training using the MAIA microperimeter and then further reading using magnifiers and/or spectacles.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 26, 2015
Actual (reported)Study Completion
December 31, 2015
Actual (reported)Last Updated
December 8, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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